The following data is part of a premarket notification filed by Lightmed Corporation with the FDA for Lightlas Multi-wavelength Medical Laser System.
| Device ID | K152688 |
| 510k Number | K152688 |
| Device Name: | LightLas Multi-Wavelength Medical Laser System |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORPORATION No. 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist New Taipei City, TW 23861 |
| Contact | Mollie Li |
| Correspondent | Mollie Li LIGHTMED CORPORATION No. 1-1, Lane 1, Pao-An St., Sec 3, Shulin Dist New Taipei City, TW 23861 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-18 |
| Decision Date | 2016-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826770673 | K152688 | 000 |